Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

Lexis Pharmaceuticals' press release announcing the launch of a new generic oral contraceptive, N.E.E. 1/35, overstated FDA's position on direct-to-consumer ads and mistakenly took credit for running the first such ads, FDA told the company in a recent regulatory letter. Specifically, the Lexis press release cited FDA's pre-launch review of Lexis' direct-to-consumer ad campaign as agency "encouragement" of the principle. "Generally, we believe that the press release has resulted in the communication of false and/or misleading concepts concerning FDA's participation in this manner," FDA said in the Feb. 8 reg letter. "We believe the press release exaggerates this effort and has misleadingly suggested that FDA 'encourages' direct to consumer advertising of prescription drugs." FDA said its position is to "neither discourage or encourage direct-to-consumer advertising of prescription drugs." The FDA ad division's "active role in providing comments, suggestions and/or other forms of guidance at your request was neither any more or less than we would provide any sponsor of pharmaceutical advertising embarking in a new area," the correspondence adds. Lexis' February launch of N.E.E. 1/35 (norethindrone/ethinyl estradiol) marked the firm's first entry into the generic oral contraceptive market. The launch included price comparison print ads in women's magazines as well as a rebate program ("The Pink Sheet" Feb. 13, T&G-1). FDA also called Lexis to task on two other aspects of the press release. The Lexis press release called the company's ad campaign the "first-ever consumer ads for prescription drugs." FDA pointed out that direct-to-consumer advertising of prescription drugs "has been around, although sporadic, prior to 1983." FDA also objected to the absence of either "full disclosure" information or product labeling accompanying the press release.

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts